Ethical Considerations in TB · 11/24/2015 5 WHO’s END TB Strategy • 95% reduction in TB deaths by 2035 • 90% reduction in TB incidence by 2035 • Zero catastrophic spending

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EXCELLENCE EXPERTISE INNOVATION

EthicalConsiderationsinTBMikeWatsonFrickNovember20,2015

Tuberculosis IntensiveNovember 17‐20, 2015

San Antonio, TX

• No conflict of interests

• No relevant financial relationships with any commercial companies pertaining to this educational activity

MikeFrick,MPHhasthefollowingdisclosurestomake:

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ETHICAL CONSIDERATIONS IN TB

Mike Watson Frick

TB/HIV Project

Treatment Action Group

Heartland TB Intensive

November 2015

The plan

• Key concepts: ethics & human rights

• Key context: zero TB campaign & endTB strategy

• Ethics and the language of TB

• Ethics and patient-centered TB care

• Ethics and protection of healthcare workers

• Ethics and involuntary isolation and detention

• Ethics and TB research

• Update on revised TB ethics guidance from WHO

• Hearing from you

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ETHICS “simply part of our life with others”

• Refers to the way we ought to live our lives, including our actions, intentions and habitual behavior

• “Ordinary ethics” – when we talk about ethics, we’re not leaping away from everyday life, but rather descending into it

• Ethical values best understood as a complex web of obligations – sometimes in alignment, sometimes in conflict

HUMAN RIGHTS“timeless expressions of fundamental entitlements of the human person”

• Universal, inalienable

• Defined by international law

• Primarily concerned with the relationship between individuals and their governments

• Governments are charged to respect, protect and fulfill

• Rights can be civil and political (e.g., freedom of movement, religion etc.)

• Rights can be economic, social or cultural (e.g., the right to health)

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• There’s a lot of overlap—especially in health

• Human rights are concrete legal expressions of ethical values (for example, non-discrimination, participation, accountability etc.)

• Not unwavering universal agreement on ethics

• Not all countries have ratified all the human rights treaties

Ethics, meet human rights

We have a lot of catching up to do when it comes to promoting ethics and human rights in the TB response.

• Until recently, unambitious global goals.

• A one size fits all approach (DOTS).

• A heavy emphasis on top-down, biomedical interventions.

• Infrequent discussions of patient education, empowerment and psychosocial support.

• Slow progress in research and development.

• Little political will mobilized to tackle the TB epidemic.

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WHO’s END TB Strategy• 95% reduction in TB deaths by 2035

• 90% reduction in TB incidence by 2035

• Zero catastrophic spending due to TB

Ethics and the language of TB

“As leaders in the TB community, NTCA urges that care be provided using the most compassionate and patient-centered approach possible. NTCA recognizes the need for non-stigmatizing language in TB services. We resolve to use non-stigmatizing language in our publications and discourse, and to promote the use of non-stigmatizing language with our partners.” NTCA

“The Union fully acknowledges that some terms that have been used for many years to describe TB activities can stigmatize people affected by TB. The Union is committed to communicating in a manner that embodies respect for all people affected by TB.” IUATLD

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What does language have to do with ethics?

“Words and gestures uncover the natureof the world and the self—hencelanguage becomes much more thana system of communications, itexpresses ethical commitments thathave become embedded ineveryday life. What is at stake inlanguage is not only to communicate, butto do so in a manner that the self-respect,dignity and honor [of others] is notharmed.” – Veena Das

Language and TB Stigma

Treatment default Treatment non-completion

Defaulter Person lost to follow-up

TB suspect Person to be evaluated for TB

Compliance Adherence

Research subjects Research participants

TB control TB prevention and care

Stigma >>> contagion, defect, disability

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Health SystemHealth System

Ethics and patient-centered TB care“Patient-centered care is oriented toward addressing patients’ priorities, not in the sense of a menu of choices, but rather as a holistic model of health care delivery that considers the patient as the central figure in the process or continuum of care.”

Physician Patient Physician Patient

O’Donnell MR, Daftary AD, Frick M, et al. Re-inventing adherence: toward a patient-centered model of care for drug-resistant TB and HIV. IJTLD [forthcoming].

Patient-centered care is a process, not an outcomePatient-centered approaches recognize that comprehensive care must be provided along a locally contextualized continuum of services.

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Patient-centered care and human rights

• Requires overcoming mindset that people with TB are non-adherent, while medicine is always efficacious.

• Requires rethinking responsibilities. Patient-centered care does not mean re-centering all responsibility back on the person with TB.

• The obligation to provide care rests with governments.

Ethics and protection of healthcare workers

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HCWs have an ethical obligation to provide care to patients, even if doing so involves risk; But there are limits to the degree of risk HCWs can be reasonably expected to take.

HCWs

Patients

FamiliesCoworkers

Society

Government• The duty of care depends on the provision of goods and services by governments and healthcare institutions.

• HCWs have multiple obligations to families, coworkers, society.

The duty of care does not exist in a vacuum

Ethics and involuntary isolation and detention

Forced treatment = never ethically justifiable

Involuntary isolation and detention = last resort measures

“Non-adherence is often the direct result of failure to engage the patient fully in the treatment process. Any program that experiences frequent refusals of care, or significant adherence problems, should take a hard look at whether it is doing everything it can to implement a patient-centered approach” WHO TB Ethics Guidance

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The Siracusa Principles

There are limits to rights-limiting measures. When is it justified to limit human rights in the interest of public health or safety?

Restrictions must be:

1) Necessary

2) Proportional to the potential harm

3) Non-discriminatory

Restricting one right cannot be taken as a justification for limiting all rights.

Photo by Maxim Dondyuk

Ethics and TB Research(as opposed to the ethical conduct of TB research)

• Shortcomings in R&D have helped give rise to many of the ethical challenges that TB programs face.

• Research can transform the way a disease is culturally perceived (e.g., moving from fatal to curable).

• Research can galvanize advocacy and clarify social or legal petitions for redress of TB-related harms.

• The benefits of research are not always equitably or fairly distributed.Without reflection, research may reinforce the disparities that drive the TB epidemic.

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R&D shortcomings give rise to ethical challenges faced by TB programs

• Weak R&D environment leaves people with TB and health systems reliant on lengthy treatment regimens with pill burdens, side effects, dosing schedules that complicate adherence.

• Limitations to TB diagnosis and treatment—still unresolved by research—have changed the nature of TB disease itself.

Limited funding limits the equity proposition of TB research from the outset…

…and means compromise is woven into the fabric of TB research itself.

1 ex: not studying drugs in optimal combination;

2 ex: desire for “clean” studies producing data with little “noise” leads to studies focused on easiest-to-treat (i.e., adults with minor cavitation, no HIV or HIV with high CD4 count)

3 ex: little research that includes most vulnerable populations (children, pregnant women, people who use methadone etc.)

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Thinking beyond informed consentDoes research generate social value?

= Evaluation of a treatment, intervention or theory stands to improve health and well being or increase knowledge.

= Research responds to global and local needs and equitably alleviates the burden of TB disease.

WHO Experts Group on TB Ethics and Human Rights

met in Geneva Nov 12–13

Update on revised TB ethics guidance

from WHO

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What’s changed since the first guidance?Clinical trials• New drugs for DR-TB (bedaquiline and delamanid)• New regimen for TB infection (3HP: RPT + INH)• New diagnostic test (GeneXpert MTB/RIF)• Disappointing results (4-month DS-TB trials, TB vaccine trials)Epidemiology/surveillance• Clearer picture of the size of the TB epidemic• Greater recognition of the burden of pediatric TB• Better understanding of DR-TB transmissionCross-cutting• Funding for research has stagnated• 3 pharmaceutical companies have left TB research• Development of Good Participatory Practices as an ethical

guidepost for TB research

New considerations in the guidance

A deeper focus on preventing and treating TB among special populations and in challenging contexts.

• Ethical issues related to pediatric TB

• Ethical issues of treating TB in prisons

• Ethical issues related to TB and migration

• Ethical issues related to suboptimal treatment of MDR-and XDR-TB (i.e., functional monotherapy)

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HEARING FROM YOU